FDA Inspection
ORTHO SOLUTIONS, LTD.ORTHO SOLUTIONS, LTD. – FDA Inspection, Apr 21, 2017
Record Details
This FDA Inspection record concerns ORTHO SOLUTIONS, LTD., with an inspection on April 21, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · d429e75f-8a85-4769-aeb6-52f1de3a474b
Inspection Facts
- Inspection number
- 1019552
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184Lack of or inadequate DHR procedures
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Other FDA inspections of ORTHO SOLUTIONS, LTD.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 10, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ORTHO SOLUTIONS, LTD.
- FDA Inspection 883139 - 2014-04-10
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